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Re: pix post# 140964

Thursday, 06/07/2018 9:02:21 AM

Thursday, June 07, 2018 9:02:21 AM

Post# of 331501
PREVIOUSLY SUBMITTED 510K

QUOTE:

They have provided guidance on how to combine the back-pain study results, along with our previously cleared 510(k), into a single 510(k) submission for obtaining expedited expanded market clearance.”, he said.

BioElectronics Receives FDA Pre-Submission Approval for its Relief of Musculoskeletal Pain Market Clearance Application https://finance.yahoo.com/news/bioelectronics-receives-fda-pre-submission-123000275.html